Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

Not Recruiting

Trial ID: NCT00111618


The purpose of this trial is to confirm a safe dose of AS1404, to be given with docetaxel, and to see whether adding AS1404 and docetaxel together improves the outcome of the treatment, when compared to docetaxel alone.

Official Title

An Open Label, Randomized, Phase II Study of AS1404 in Combination With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - Age equal to, or greater than 18 years

   - Eastern Cooperative Oncology Group (ECOG) performance status 0-2

   - Life expectancy greater than or equal to 3 months

   - Histopathologically confirmed adenocarcinoma of the prostate

   - Metastatic progressive androgen-independent prostate cancer with no previous
   chemotherapy treatment

   - At least 4 weeks off of flutamide and 6 weeks off of bicalutamide and nilutamide

   - Patients who have not undergone surgical castration must continue treatment with an
   luteinizing hormone-releasing hormone (LHRH) agonist. In those patients where, for
   some reason, the LHRH agonist has been discontinued prior to entry on the study, it
   should be reinstituted and disease progression must be documented.

   - Hematological and biochemical indices at screening within the following ranges:

      - An absolute neutrophil count of greater than or equal to 1.5 x 10^9/L;

      - A platelet count of greater than or equal to 100 x 10^9/L;

      - A hemoglobin level of greater than or equal to 10 g/dL.

   - Adequate hepatic and renal function, as defined by:

      - Serum bilirubin less than or equal to upper limit of normal (ULN);

      - SGOT and/or SGPT less than or equal to 1.5 x ULN concomitant with alkaline
      phosphatase less than or equal to 2.5 x ULN;

      - Serum creatinine less than or equal to 120 micromol/L or creatinine clearance
      greater than or equal to 60 mL/min.

   - Be willing and able to provide written informed consent and, in the opinion of the
   Investigator, be able to comply with the study assessments and follow-up

   - Serum testosterone no greater than 50 ng/mL (chemically castrated patients only)

Exclusion Criteria:

   - Decreasing PSA levels after antiandrogen withdrawal

   - Previous chemotherapy treatment for prostate cancer

   - Patients who have received blood transfusions or growth factors to aid hematological
   recovery within two weeks of scheduled baseline visit

   - Concurrent severe and/or uncontrolled co-morbid medical condition within 2 weeks of

   - Previous exposure to AS1404 or other vascular targeting agents

   - Clinically significant cardiac arrhythmias and known QTc prolongation (interval >450

   - Evidence of severe or uncontrolled systemic disease that, in the opinion of the
   Investigator, might interfere with the patient's participation in the study

   - A history of alcoholism; drug addiction; or any psychiatric condition, which, in the
   opinion of the Investigator, would impair the patient's ability to comply with study

   - A history of hypersensitivity to taxanes or other drugs formulated with polysorbate 80

   - Treatment with the following medications within two weeks of AS1404 administration or
   the expected need for such treatments during the study period:

      - Medications known to modulate serotonin;

      - Medications known to affect the QT interval;

      - Current treatment with, or the expected need during the treatment period for
      ketoconazole, erythromycin, troleandomycin, and/or cyclosporine. The use of other
      agents known to induce, inhibit, or that are metabolized by cytochrome P450-3A4
      should be undertaken with caution.

   - Concurrent or previous malignancy of a different tumor type within five years of
   starting the study, except for adequately treated non-melanoma skin cancer

   - Clinical or radiological evidence of central nervous system (CNS) metastases

   - Symptomatic peripheral neuropathy greater than or equal to National Cancer Institute
   (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade II

   - Evidence of any other significant clinical disorder or laboratory finding that, in the
   opinion of the Investigator, compromises the patient safety during study participation

   - Participation in any prostate cancer investigational drug study in which the study
   drug has not subsequently obtained a product license

   - Any other concurrent treatment for prostate cancer (with the exception of palliative
   radiotherapy) other than that specified in the protocol, including the use of herbal
   remedies, (e.g. saw palmetto)


drug: AS1404 (DMXAA)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ruth Lira

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